Declaration of Incorporation for Partly Completed Machinery: Content and Model Layout

It travels with the assembly to the integrator who builds the final machine.

The Regulation applies from 20 January 2027 and replaces Directive 2006/42/EC, which applies until 19 January 2027 through national law. The declaration therefore moves from Annex II, point 1, section B of the Directive to Article 22 and Annex V, Part B of the EU Machinery Regulation.

The sections below cover the 9 points, a model layout, the comparison with the EU declaration of conformity, access and retention, the CE marking of the final machine and the 2027 change.

What Is a Declaration of Incorporation?

The EU declaration of incorporation of partly completed machinery (Article 22 of Regulation (EU) 2023/1230) accompanies an assembly that cannot perform a specific application by itself and is only intended to be incorporated into machinery, in place of the CE marking and the EU declaration of conformity that the final machine receives.

Article 3(10) calls that assembly partly completed machinery, "not yet machinery", and Article 2(1), second subparagraph, brings it into scope.

The declaration is one of three Article 11 deliverables, next to the Annex IV, Part B documentation and the Annex XI assembly instructions.

No Article 25 procedure applies, so the manufacturer issues it under its sole responsibility (Annex V, Part B, point 3). The concept, its borderline cases and the full Article 11 duties are covered under partly completed machinery: definition and obligations.

The 9 Points of Annex V, Part B

Annex V, Part B of Regulation (EU) 2023/1230 sets 9 points for the declaration of incorporation, one more than the 8 particulars of Annex II, point 1, section B of Directive 2006/42/EC.

Article 22(1) requires the declaration to state that fulfilment of the relevant Annex III requirements has been demonstrated. The manufacturer identifies those requirements through its risk assessment, to which Annex III, Part B, point 5 applies the general principles. The table sets out what each of the 9 points records.

Article 22(1): the relevant requirements are identified in the machinery risk assessment (Annex III, Part B, point 5).

The heading of Part B carries a "No ..." field, and numbering the declaration is optional for the manufacturer.

Standards and Common Specifications with Their Date (Point 6)

Point 6 requires the references of the standards or common specifications applied, including the date of the standard or of the common specification. Other technical specifications are listed with their date too, and partial application is specified by part.

The EU declaration of conformity asks for a different date: Annex V, Part A, point 7 requires the date of publication of the reference in the Official Journal, so a copied conformity format records the wrong date.

The Undertaking to Transmit Information (Point 7)

Point 7 is an undertaking to transmit relevant information on the partly completed machinery in response to a reasoned request by the national authorities, including the method of transmission, without prejudice to the intellectual property rights of the manufacturer.

The method of transmission is a concrete entry, such as paper or electronic dispatch, so an authority knows in advance how the information reaches it.

No Putting into Service Before the Final Declaration (Point 8)

Point 8 states that the partly completed machinery shall not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the Regulation.

This sentence ties the supplier's declaration to the integrator's EU declaration of conformity under Article 21. The supplier covers only the relevant requirements of its assembly; conformity of the complete machine is declared by that machine's manufacturer after its own Article 25 procedure.

Conformity with Other Union Acts (Article 22(3))

Article 22(3) and Annex V, Part B, point 5 of Regulation (EU) 2023/1230 require the declaration of incorporation to include, where appropriate, a sentence declaring conformity with other Union legal acts that require an EU declaration of conformity, with their publication references.

A complete machine instead uses one single EU declaration of conformity for all acts concerned (Article 21(3)). Which acts belong in the sentence depends on the product.

Model Layout of a Declaration of Incorporation

A model layout of a declaration of incorporation follows the 9 points of Annex V, Part B of Regulation (EU) 2023/1230 in their order, from the identification of the partly completed machinery in point 1 to the signature block in point 9.

The nine slots below follow the wording of Annex V, Part B in the consolidated text of Regulation (EU) 2023/1230 on EUR-Lex.

1. Identification: product, type, model, batch or serial number.
2. Manufacturer: name and address, and the authorised representative where applicable.
3. Responsibility statement: issued under the sole responsibility of the manufacturer.
4. Object: traceable identification, with a colour image where needed.
5. Requirements sentence: Annex III requirements, Annex IV, Part B documentation, other Union acts where appropriate.
6. Standards: references with their date.
7. Undertaking: information on reasoned request, with the method of transmission.
8. Putting-into-service statement.
9. Signature block: place and date of issue, name, function, signature.

Full annex text: Regulation (EU) 2023/1230 on machinery: full text.

The Commission's Guide to application of the Machinery Directive 2006/42/EC, Edition 2.3 (April 2024), states that the declaration and the assembly instructions need not share a format. Point 9 reads "Signed for and on behalf of"; Article 22 names no authorised representative as signatory.

Declaration of Incorporation vs Declaration of Conformity

A declaration of incorporation states which relevant requirements an assembly meets and carries no CE marking, while an EU declaration of conformity under Article 21 of Regulation (EU) 2023/1230 states that the complete product meets all applicable requirements after an Article 25 procedure and comes with the CE marking. The table compares the two documents in nine provisions.

All declarations side by side: machinery documentation: technical file, instructions and declarations compared.

The integrator draws up the EU declaration of conformity for the final machine after its own Article 25 procedure; the supplier's declaration of incorporation feeds that work but never replaces it. The integrator's document is explained under EU declaration of conformity for machinery.

How the Declaration Reaches the Integrator

Article 11(8) of Regulation (EU) 2023/1230 lets the declaration of incorporation either accompany the partly completed machinery or be reached through an internet address or machine-readable code given in the assembly instructions. The integrator therefore looks in two places: the delivery itself and the assembly instructions.

The Declaration Inside the Assembly Instructions (Annex XI, Point 3)

Annex XI, point 3 of Regulation (EU) 2023/1230 requires the assembly instructions to contain the EU declaration of incorporation or the internet address or machine-readable code where it can be accessed.

Annex XI, point 2 lists 14 items, (a) to (n); item (n), the version of the assembly instructions matching the model, is new. Article 11(7) sets their language: one easily understood by the person who incorporates the partly completed machinery, as determined by the Member State concerned.

Digital Declarations and the 10-Year Retention

A digital declaration of incorporation stays accessible online for at least 10 years after the partly completed machinery is placed on the market (Article 11(8)), and the manufacturer keeps the declaration and the technical documentation for at least 10 years after placing on the market (Article 11(3)).

The EU declaration of conformity has its own digital rule in Article 10(8): it stays online for the expected lifetime of the product and at least 10 years after placing on the market or putting into service. The same choice for complete machines is explained under machinery instructions and the new digital format rules.

From Declaration of Incorporation to the CE Marking of the Final Machine

Partly completed machinery never bears the CE marking under Regulation (EU) 2023/1230; the CE marking appears on the final machine once its manufacturer has completed the Article 25 procedure and drawn up the EU declaration of conformity. Point 8 of the declaration of incorporation links the two steps.

Whoever markets the final machinery under its own name or trademark is its manufacturer under Article 3(18), with the Article 10 duties, from Annex IV, Part A documentation to the Article 24 CE marking. The declaration of incorporation shows which requirements the supplier has already covered.

Under Article 13(2) of Directive 2006/42/EC, the assembly instructions and the declaration accompany the partly completed machinery until it is incorporated and then form part of the technical file of the final machinery.

No article of Regulation (EU) 2023/1230 reproduces that paragraph; Annex IV, Part A, point (j) puts both documents into the final machine's technical documentation "where appropriate". The CE marking is affixed before placing on the market or putting into service (Article 24(2)), as set out under CE marking of machinery.

How to Issue a Declaration of Incorporation in Compliance

Issuing a declaration of incorporation under Regulation (EU) 2023/1230 takes five steps, from identifying the relevant requirements to keeping the declaration reachable for at least 10 years. The five steps are listed below in order.

1. Identify the relevant Annex III requirements through the risk assessment of Annex III, Part B, point 5.
2. Compile the Annex IV, Part B documentation, points (a) to (m).
3. Fill in the 9 points of Annex V, Part B.
4. Supply the declaration with the product, or its address or code in the assembly instructions.
5. Keep it for at least 10 years and tell the integrator that the final machine needs its own Article 25 procedure, which the machinery conformity route finder identifies.

What Changes from Annex II, Point 1, Section B on 20 January 2027

From 20 January 2027, a declaration of incorporation for partly completed machinery placed on the market follows Article 22 and Annex V, Part B of Regulation (EU) 2023/1230; until 19 January 2027, Annex II, point 1, section B of Directive 2006/42/EC applies through national law, and there is no parallel period in which the manufacturer may choose.

Annex XII of the Regulation, the correlation table, maps Directive Annex II to Regulation Annex V, Article 13 to Article 11 and Annex VI to Annex XI. The table compares seven provisions, based on the Directive 2006/42/EC text on EUR-Lex.

All dates: Machinery Regulation timeline.

Products placed on the market under the Directive before 20 January 2027 may continue to be made available (Article 52(1)). The full correspondence between both acts is set out under Machinery Regulation vs Machinery Directive.

Language Rules and Importers Handling a Declaration of Incorporation

A declaration of incorporation also passes through national language rules and importers' hands, and Germany already sets one such rule for 2027.

Article 22(2) of Regulation (EU) 2023/1230 requires the declaration to be translated into the language or languages required by the Member State in which the partly completed machinery is placed or made available on the market.

Germany requires German for the declaration and the assembly instructions from 20 January 2027 (§ 2 MaschinenDG of 2 December 2025, BGBl. 2025 I Nr. 302). Three national and operator points are listed below.

• Germany: § 2 MaschinenDG, see machinery rules in Germany.
• Importers: Article 14, records kept at least 10 years (Article 14(7)), see importer obligations for machinery.
• Great Britain: Supply of Machinery (Safety) Regulations 2008 (S.I. 2008/1597), amended by S.I. 2026/867 from 20 January 2027, see machinery rules in the United Kingdom.

The Commission proposed in COM(2025) 504 of 21 May 2025 (2025/0134(COD)) that declarations of incorporation be drawn up in digital format and reached through an internet address or machine-readable code (proposed Article 11(2) and 11(8)). The proposal is pending as of 12 November 2026; see amendments to the Machinery Regulation.

Declaration of Incorporation Questions

Two questions recur: whether the declaration needs a number, and whether it may cover more than one machine.

Does a declaration of incorporation need a number?

No, numbering the declaration of incorporation is optional for the manufacturer under Annex V, Part B of Regulation (EU) 2023/1230.

Can one declaration of incorporation cover several partly completed machines?

Annex V, Part B, point 1 of Regulation (EU) 2023/1230 identifies the partly completed machinery the declaration covers by product, type, model, batch or serial number. Point 4 requires an identification that allows traceability.